On 13 March 2026, the European Commission withdrew the marketing authorisation for Zoledronic acid medac (zoledronic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, medac Gesellschaft fur klinische Spezialpraparate mbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Zoledronic acid medac was granted marketing authorisation in the EU on 3 August 2012 for the prevention of skeletal related events and the treatment of tumour\-induced hypercalcaemia (TIH). The marketing authorisation was initially valid for a 5\-year period. It was then granted unlimited validity in 2017\. Zoledronic acid medac is a generic medicine of Zometa. There are other generic medicines of Zometa authorised and marketed in the EU.
Therapeutic Indication
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour\-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour\-induced hypercalcaemia (TIH).
Therapeutic Area (MeSH)
ATC Code
M05BA08
ATC Item
N/A
Pharmacotherapeutic Group
Drugs for treatment of bone diseases
Active Substance (Summary)
INN / Common Names
EMA Name
Zoledronic acid medac
Medicine Name
Zoledronic acid medac
Aliases
N/ANo risk management plan link.